COUNTER-COVID - Oral imatinib to prevent pulmonary vascular leak in Covid19 * a randomized, double-blind, placebo controlled, clinical trial in patients with severe Covid19 disease

Phase 2

Completed

• Conditions: COVID-19 disease; Pulmonary edema; 10024970

• Registration Number: NL-OMON49996
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-02-01
• Results First Posted: 2021-06-17
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 386

Inclusion Criteria

- Age >18 years
- Hospital admission with proven SARS2-Covid19 infection
- Hypoxemic respiratory failure (SpaO2 <94% or, PaO2 <9kPa)
- Ability to give informed consent.

Exclusion Criteria

- Pre-existing chronic pulmonary disease
- Former diagnosis of Interstitial pulmonary disease
- Former diagnosis of COPD 4 or FEV1<30%pred
- Previous DLCO <45%
- Total lung capacity (TLC) < 60% of predicted
- Lung cancer with non-surgical treatment in last year
- Chronic home oxygen treatment
- Pre-existing heart failure with a known left ventricular ejection fraction
<40%
- Active treatment of hematological or non-hematological cancer with targeted,
immuno- or chemotherapy or targeted radiotherpay in the last year
- Inability to provide informed consent
- Any subject who had received any investigational medication within 1 month
prior to the start of this study or who is scheduled to receive another
investigational drug during the course of this study
- Active liver disease, porphyria or elevations of serums transaminases >5 x
ULN (upper limit of normal) or bilirubin > 1.5 x ULN
- History or suspicion of inability to cooperate adequately.
- White blood count < 4.0^109/l
- Hemoglobin < 6.0 mmol/l
- Thrombocytes < 100^109/l
- Pregnant femae subjects (pregnancy test will be performed in all women of
childbearing age prior to inclusion)
- Breastfeeding female subjects
- Use of strong Cyp3A4 inductors, including the following drugs: Carbamazepine,
efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan,
nevirapine, primidon, rifabutine, rifampicine
- Concomittant use of chloroquine or hydroxychloroquine.
- QTc >500msec at baseline.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the time to liberation from ventilation and<br /><br>supplemental oxygen and alive during a 28 day period after randomization</p><br>